At Roche, you can be your authentic self and will be appreciated for your unique qualities. Our culture fosters personal expression, open dialogue, and genuine connections. Here, you are valued, accepted, and respected for who you are—creating an environment where you can grow both personally and professionally. Together, we aim to prevent, stop, and cure diseases and ensure that everyone has access to healthcare—today and in the future. Join Roche, where every voice matters. The Position Within the LTO unit—which encompasses Regulatory, Quality, and Medical Information departments—we are seeking a proactive, eager-to-learn individual to provide operational support to the LTO unit in tasks involving support and management of systems and databases, particularly regulatory ones, as well as administrative support to the unit. **Your Main Responsibilities:** * Superuser and trainer for RIM (VEEVA) within the Regulatory Affairs unit * Support implementation and monitoring of RIM (VEEVA) * Annex splitting (Technical Dossier and Patient Information Leaflet) and tracking until approval: Perform correct preparation and splitting of Technical Dossiers and Patient Information Leaflets in accordance with quality standards, regulatory requirements, and using the platform designated by the Spanish Agency for Medicines and Health Products (AEMPS). * Conduct product validations on the AEMPS website * Monitor authorizations in the AEMPS Special Situations Medicines database * Management of internal databases: Maintain and update departmental databases, ensuring integrity and traceability of product regulatory information * Process fee applications and track associated payments * Manage budget requests to service providers * Collect and organize materials for reports and communications * Monitoring of legislation: Review for updates to regulatory legislation to inform the team, which will subsequently assess impact * Administrative support to the LTO Unit leadership (meeting coordination, scheduling, minutes, room bookings, etc.). Occasionally, provide operational support to the Local Evidence Generation unit * Responsible for documentation, archiving, and retention of electronic and paper records (paper records are now largely residual) * Documentation and information accessible to the role is generally confidential **Who You Are:** * Professional experience: Minimum 1 year of experience (including internships) in a Regulatory department or similar function within the pharmaceutical industry or a CRO * Experience with the RIM (VEEVA) tool and other systems such as splitting platforms, RAEFAR, and the Special Situations Medicines platform will be highly valued * Academic background: Bachelor’s degree or equivalent preferred in Health Sciences, or training/experience in Regulatory Affairs * Highly digitally competent, capable of managing various software and databases * Language: High level of English and Spanish, both spoken and written **Other Competences You Bring:** * Strong organizational and planning skills * Analytical ability * Attention to detail * Proactivity and problem-solving capability * Teamwork and ability to manage projects autonomously * Communication skills * Interpersonal skills and ability to understand scientific and health-related concepts * Demonstrated high integrity in handling privileged information and sensitive databases * Interest in and aptitude for adopting new digital tools Who We Are A healthier future drives us to innovate. More than 100,000 employees worldwide work together to advance scientific progress and ensure that everyone has access to healthcare—today and for future generations. Through our commitment, over 26 million people are treated annually with our medicines, and more than 30 billion tests are performed using our diagnostics products. We encourage one another to explore new possibilities, foster creativity, and set ambitious goals to deliver life-changing healthcare solutions. Together, we can shape a healthier future. **Roche is an equal opportunity employer.**